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Pipeline Progress at Isis Pharma

Isis Pharmaceuticals, Inc. (ISIS) continues to progress well with its collaboration agreement with GlaxoSmithKline (GSK), which is focused on the discovery and development of new therapeutics against targets for rare and/or serious diseases.

In Oct 2013, Isis Pharma earned a milestone payment of $7 million following the addition of candidate ISIS-GSK3Rx under its collaboration agreement with Glaxo.

Isis Pharma recently initiated a phase I study on pipeline candidate, ISIS-GSK3. The candidate is being developed to inhibit the production of an undisclosed target for a common viral infection.

With the initiation of the phase I study, Isis Pharma earned another $3 million milestone payment from Glaxo.

While Isis Pharma is responsible for the development of ISIS-GSK3Rx to the phase II proof-of-concept stage, Glaxo has an exclusive option to in-license the program thereafter and develop and commercialize the candidate. Isis Pharma is eligible to receive additional pre-licensing milestone payments from Glaxo as it progresses with the development of candidate ISIS-GSK3.

Isis Pharma is also entitled to receive double-digit royalties on sales of ISIS-GSK3.

Meanwhile, last week, Isis Pharma announced that it will evaluate a higher dose of ISIS-SMNRx in children affected by spinal muscular atrophy (SMA).

As a result, Isis Pharma plans to add a 12 mg cohort to the ongoing phase Ib/2a study which is evaluating ISIS-SMN in children suffering from SMA. The study with the higher dose will commence in 2014.

The pipeline progress at Isis Pharma is encouraging. We remind investors that Kynamro is Isis Pharma’s only approved product, developed in collaboration with Genzyme, a Sanofi (SNY) company for cholesterol management in patients suffering from homozygous familial hypercholesterolemia (HoFH). The product was launched in the U.S. in Mar 2013.

We are positive on Isis Pharma’s agreement with Glaxo which covers up to six programs. It not only validates Isis Pharma’s antisense technology, it also provides the company with funds in the form of upfront, milestone and other payments.